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A week ago, my wife Debra broke her hip in a fall. The experience has given me a better appreciation of our health care system. While not perfect, I am impressed with the speed and quality of the care American style. That is, the for profit hospital was interested in her satisfaction as a customer. They were interested in making her happy, so they can be known as a customer centric facility. In today’s social media world customer ratings matter. They touted their ratings on billboards placed in their lobby from several sources such as Healthgrades and US News and World Report. They were aware that she may go to customer rating sites after her discharge and did whatever they could to ensure good feedback.

I frankly expected the typical poor hospital experience based on past interactions with emergency rooms and being admitted for surgery. The last time I was hospitalized was about 20 years ago. That experience was characterized by a diffident nursing staff, a cramped double room with a moaning roommate, and of course lousy food. Move ahead 20 years and everyone at this hospital was interested in ensuring a positive experience.

My underlying point in this is that those who advocate the federalization of healthcare may not like the result. I have had few positive experiences with government agencies. It is not that they are staffed by bad people, it is that they do not make customer service a priority. They do not have to. We have one choice for paying our taxes, getting our passport, getting through airports, and that is Uncle Sam. Sometimes he can be slow, unfriendly, rigid, and lacking in empathy.

In the case of my wife’s emergency surgery I had choices and could accept or reject the hospital and surgeon. Admittedly, once my immobile and in agony wife was brought in, we were kind of a captive audience. Still they knew she could request a move to another hospital and went the extra mile to ensure she stayed. My personal physician did not have privileges there so it was a serious consideration to move.

What I noticed most was the staff always asking if she was satisfied. This was from the ER nurses to the aides taking her meal orders. She felt like a valued customer rather than a burdensome patient. While she was anxious to get home she felt comfortable staying there. The lesson I learned was the enormous opportunities that still exist in healthcare to delight the patient. The hospital staff explained that all the rooms in the new wing were now singles because they knew patients valued their privacy. The visitors have free valet parking. Nice touches.

I know Bernie Sanders thinks government would do a better job running the healthcare system. Somehow I doubt single rooms and valet parking would be part of their plan. I also doubt customer satisfaction would be anywhere as a top priority. Yes, I am confident care would be adequate under a government run system. For my wife the stress of breaking her hip and going through emergency surgery was enough, and adequate care was not what we wanted. We wanted customer centric care and the for profit model provided it.

I thought about how much more we can do to unleash free market customer centric care. We can lower costs and improve care just by letting for profit companies compete. Profit and free choice are powerful motivators for innovation. We should encourage more of it rather than hope government is the solution. Just think the post office versus FedEx as the analogy. I know which I would choose.

The widely reported story that Amazon is considering entering the prescription drug market has made current drug sellers nervous. Could Amazon revolutionize drug sales? Or, would they just be another mail order supplier in a crowded market? The answer is unclear.

Amazon certainly has the strength to cut deals with drug companies, insurers and major employers to supply drugs. If a major insurance company wanted to work through Amazon to try to cut costs it is likely they could shave some expense. I do not, however, understand yet how Amazon would be able to fundamentally change drug delivery or pricing.

Drug companies have established a complex supply chain with numerous levels of prices across different customer categories. Drug companies have no problem quickly supplying patients through drug stores, mail order houses, or in store pharmacies at supermarkets/big box chains. While certainly a convenient place to shop its many product categories, are there advantages for customers buying their drugs there?

I have increasingly bought more things on Amazon because I get free delivery through Prime. Their service is reliable. It is nice to be able to buy directly from them or their listed sellers. That being said, Amazon is still just a giant online market. Patients already have a vast array of options filling their prescriptions and I never heard anyone complaining how hard it is to fill a prescription. Unless Amazon can significantly lower consumer price, or save insurers lots of money, then the game changing aspect of their market entry is unclear.

I love Amazon and was lucky enough to hold on to my 200 shares bought at $35 many years ago. As big a fan as I am of their company, to change how drugs are sold is not easy. Maybe all Amazon wants to do is be another online option and grab a share of the huge market. Certainly, they have an enormous customer base who would be happy to add drugs on with other purchases.

Of course, Amazon is an innovator and maybe they will be able to add consumer value to drug purchases. Perhaps they will be able to launch retention and compliance programs using their customer research base. Alternatively, they may be able to innovate in disease and drug education. Their major asset is consumer trust and that should never be underestimated. Amazon has a team evaluating entering the market and my guess is they will enter, even if just as an ordinary supplier at the start. Long term I suspect they are thinking of ways to shake up the supply chain to offer substantial discounts to their customers.

My question to the DTC community is why can’t we come together with FDA and make DTC advertising more understandable.

I am not talking just about risks but also benefits and indications. We are all letting the approved label dictate how we say what we say. That label information is generally not consumer friendly. Consumers see advertising, not as a whole sales pitch, but merely the start of a buying process. DTC, because of regulations, seems to be treated as requiring an entire pitch where virtually everything must be discussed. Look at cancer advertising for example on non small cell lung cancer. I’ll use Keytruda as an example which is required to say it is indicated if PD-L1 is positive and there are tumors with no abnormal EGFR or ALK gene. Huh? Merck has to say it but does any consumer know what any of that means? I doubt it.

What we have are technically oriented government regulatory bureaucrats in a non-technical DTC world. They should spend their time making sure everything said is true but also understandable. Instead of forcing Merck to discuss abstract qualifications on who might benefit, consumers would be better served knowing more about clinical results. Wouldn’t it be better to say Keytruda only benefits a segment of lung cancer patients and only your doctor can say if you might benefit? After all, patients do not self diagnose PD-L1 or their gene abnormalities.

FDA can make the 60 or 90 second ads much more consumer friendly and increase comprehension if they acted more like common sense regulators. They know many ads are data crammed and difficult to follow but it is their view that the label is like the Ten Commandments. Thou shall not deviate. So we get required language that is just wasting valuable air time that might be redirected towards giving consumers information they need and more importantly understand. I know Merck would probably like to do that. I also think OPDP would like it that way because I know the people there are trying to do right. Do we really think Congress intended consumer confusion in the 1970s when they wrote the regs never contemplating DTC?

Has OPDP pushed back on the Congressional committee regulating drug promotion that we need new promotional regulations? We can recognize that consumers just want mass media advertising to inform them that something might help them. They do not need the whole story rather just enough information to ask their doctor or search the Internet. Using the excuse that the regulations require all this complexity is abdicating the role FDA should have. We want drug DTC claim ads to be accurate and disclose serious risks. Surely, there is a better way. It will take FDA, Congress and drug makers to collaborate to determine how to improve. This is simple really and FDA should lead that effort.

Does anyone feel that we have done the proper job educating consumers when arcane medical terms are dominating DTC? Regulators tick off required boxes on their label checklist for DTC knowing full well consumers are often left clueless. My suggestion is OPDP have hearings on how to completely over haul DTC communication for today’s media environment, instead of using the excuse that they are captive to regulations written almost 50 years ago.

In what may be a major step towards reducing the litany of risks presented in DTC television ads, the FDA released their new study that shows that less risks presented is better for consumer comprehension and retention. While saying further study is needed, FDA cleared the way for perhaps eventually changing its guidance on the number of required risks presented. This study, originally posted for public comment in January 2015, saw the results published August 2017 in an online research journal.

FDA studied alternate risk disclosure in three categories for this study. Insomnia, depression, and high cholesterol were tested with reduced risk disclosure. While full details were not yet published the conclusion is that consumers remembered more when less was presented. We all know the current approach is not optimal because consumers get bombarded with so many risks and side effects, both in voice overs and on screen supers.

So here we are 20 years into DTC on television and we get the widely expected answer from the FDA study. While this study is better late than never the FDA says further research is needed. FDA would be wise to issue a new guidance soon giving drug makers the chance to reduce the number of risks and side effects. Consumers could immediately benefit by retaining more of the important information. I am even supportive of keeping the ads just as long with fewer risks discussed. Supers could kept on the screen longer and a slower voice speed could be used for discussing risks.

FDA has lots on its DTC research agenda, but this area of risk presentation is of major importance. Action should be a priority because consumers are overwhelmed with risk information under current requirements. The goal of all involved in DTC should be helping consumers get comprehensible risk information. The shortened risk requirement would help in achieving that goal.

The Vaccine makers have been very active using DTC to build awareness for some very serious diseases. Prevnar 13 from Pfizer has had a high spend campaign for its pneumonia vaccine. HPV has also been prominently promoted by Merck for Gardasil. Recently two new vaccines for meningitis B have hit the market and are going head to head. Pfizer’s Trumenba and GSK’s Bexsero both are going after the 10-25 year old market.

Meningitis B is a very serious bacterial disease involving inflammation of the spinal cord or brain. While rare it is deadly for about 10% of those afflicted and causes lifelong damage in many more who survive. About 10% of us have the bacteria in our saliva but overwhelmingly it does not cause meningitis. For about 600-1000 people annually the disease is devastating because it rapidly can cause death.

Trumenba became available in late 2015 and Bexsero a few months later. Trumenba began heavy DTC 3Q 2016 with Bexsero starting this June. Analysts estimate the meningitis market at about $2 billion. These are interesting case studies on DTC for a rare disease. The odds of getting meningitis are very low but the impact is so devastating that physicians, young adults and their parents are being advised by the CDC to consider these vaccines.

Drug makers have been criticized by some physicians and consumer groups for using fear based campaigns for vaccines. Why scare teens and parents? Is it right to use fear as a motivator in these DTC ads? Is it ethical to show the devastation of a disease that is rare to incentivize people to get vaccinated?

Yes, it is because untreated meningitis consequences are so bad. The vaccine is safe. It is moderate in price. The cost is usually covered by college health clinics but even self pay is reasonable at $350-600 for the series of injections. The ads for both vaccine brands are hard hitting and are directed at parents to show what could happen if the child got meningitis B. Of course, the drug makers want to increase the use of their vaccines and they know the market is wide open and incidence of use is currently low. They are trying to warn parents and yes to scare them. Sometimes we need to be scared into action. I see nothing wrong in these ads because the disease is a real, albeit low risk, and can be controlled with vaccines.

Would we have massive outbreaks of meningitis B without these vaccines? No, but saving lives and long term disability of teens and college aged kids is the issue. Society needs to balance the cost to payers for the vaccine versus the risks to the young adult population. Because the disease can spread so quickly any campus that gets a case will cause widespread fear across the community.

We want drug makers to invest in disease prevention for what we see now and may face in the future. If drug makers can develop markets through DTC they will be willing to devote more R&D investment to the vaccine segment. Vaccines and antibiotics are generally lower profit categories because use is short term. Let’s hope for success for current vaccines being advertised because one day we will need to be protected from a pandemic and must have a well developed vaccine infrastructure at big pharma.

Many recent FDA warning letters involve what they say are distracting visuals during risk discussion. Last year Otezla and Toujeo were cited for that. A recent study using eye tracking reinforced their view that visual backgrounds on TV ads are potentially hurting comprehension of risks. Drug makers frequently mention some of the risks using supers on screen.

This FDA research completed in 2016 said that consumers do not absorb information well from those supers when there are distracting visuals. Of course, what is distracting is a subjective judgement from the FDA reviewer. My concern on citing drug makers for distracting visuals is the lack of evidence for that specific ad other than reviewer opinion. I understand FDA cannot quantitatively prove distraction for every TV ad they cite and must use informed judgement. I would hope, however, that FDA is consistent between reviewers and does not change over time. In a past column I said I did not think the Otezla or Toujeo ads were any different than many others not cited by reviewers.

The problem with the fair balance requirement is that consumers are bombarded with information that may meet an FDA requirement but not be meaningful in terms of consumer understanding. FDA is studying the potential use of less warning information under the theory that less information may be better absorbed. My concern with this risk presentation is DTC is held to a different standard than every other advertising category for lawful products. Yes, drugs are different than most categories because they can cause harm. I recognize the need for telling consumers that drugs are potentially dangerous. The current litany of risk approach is, in my view, ineffective since a long list is not likely to be absorbed.

The issue is the role of warnings and risks in a television or print ad where time and space is limited. Drug ads are meant to inform consumers of an option for treatment and that is just the beginning of the pathway to prescription. The decision to prescribe any drug is an important one and side effects and risks are important for both physician and patient to understand. My view has been that only the most serious risks with the most harmful consequences should be disclosed in an ad and some quantitative odds should be mentioned. Any more than that is not particularly useful in the ad awareness stage. I clearly would want to know if anyone has died taking the advertised drug and the odds of it happening. I do not really need to hear a litany of possible non-fatal risks at the ad stage.

I hope the drug makers and FDA can work out a DTC risk and warning strategy that meets consumer needs. Consumers should be educated on benefits and risks but fair balance must be re-evaluated in the context of what consumers can meaningfully remember in 60 seconds or one page.

The Novartis psoriasis drug Cosentyx has taken an interesting approach on use of a celebrity. Rather than have a celebrity alone plug a drug this new ad mixes Cyndi with regular folks. It makes her seem like just another psoriasis sufferer who happens to be a famous pop star rather than the celebrity spokesperson for a drug. The difference is subtle but important. You can see the add on ispot.tv.

Celebrities are a mixed bag when promoting a drug. They can be effective or polarizing depending on how they are used. Some recent celebrity campaigns illustrate that a celebrity can be the star as well as one of the cast. Jennifer Anniston is great in Shire’s disease ed ad Eyelove. She is clearly the star and although we know that she is acting she is warm, and believable.

Here, Cyndi Lauper is being used as a member of a community that suffers from an embarrassing condition. She is not even identified with her last name but most of us would remember her, at least those over 40 years old. I like the approach which puts a celebrity with us regular folks rather than lecturing us as the obvious paid spokesperson.

Most of us know that a celebrity is not usually a knowledgeable medical expert. Having a celebrity tell us about a drug therefore has risks that we see them as paid endorsers who may not really use or like the product. In this Cosentyx ad, however, Cyndi Lauper comes across as sincere and believable. She is one of three psoriasis sufferers in the vignette ad and her presence gets attention without being dominant.

This is not the only ad to blend real people with celebrities. Enbrel does a nice job using golfer Phil Michelson with a regular person to discuss psoriatic arthritis. Both Enbrel and Cosentyx appear to recognize that celebrity use may be enhanced by toning down their star power by mixing them in with regular folks. That works in these two cases and I am not saying a celebrity cannot work being the sole presenter. My view is celebrities work well for disease education as the sole presenter because they are believable in highlighting a disease or condition. When you plug a brand, however, they may become less credible carrying the message. That does not mean it will not be effective just that it takes the right celebrity to be a sole branded spokesperson.

We all remember Sally Field was great plugging osteoporosis drug Bonita and Blythe Danner pulls it off for Prolia. There is no hard rule when you should use the celebrity as the star or mix them in with real folks. Consumers can tell, however when a celebrity is just hawking a product for money versus actually a user or concerned about a disease. There are many who make living hawking dubious products and it is obvious they have little concern about the product efficacy.

The Cosentyx campaign “See Me” has been working well for the last two years and has done good work adding celebrity Cyndi Lauper while maintaining its core strategy and executional style.